NaviNetics D1 Stereotactic System

FDA 510(k) K210700 · Navinetics, Inc.

Substantially Equivalent

510(k) numberK210700

Submission

Device name
NaviNetics D1 Stereotactic System
Applicant
Navinetics, Inc.
Rochester, MN, US
Received
March 9, 2021
Decision date
June 17, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HAW – Neurological Stereotaxic Instrument
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4560
Specialty
Neurology

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Questions and answers

When was NaviNetics D1 Stereotactic System cleared by the FDA?

NaviNetics D1 Stereotactic System (K210700) received a 510(k) decision of Substantially Equivalent on June 17, 2021, 100 days after the submission was received.

What is the product code of K210700?

The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.